Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that cons

FDA device recall Z-0363-2014 · posted 2013-11-19 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

Action taken

Stryker Medical sent a Medical Device Notification letter dated October 23, 2013, to all affected consignees. The letter described the recalled product, potential injuries associated with the side rail sticking, as well as providing preventive measures to be taken to mitigate the risk. Consignees were directed to locate the beds listed in this notice, ensure that the siderails have been inspected and adjusted, as required, continue to routinely inspect the siderails and functionality using the enclosed, enhanced product maintenance information. Problems and concerns should be addressed to Stryker at (1-800-327-0770, option 2). Consignees were asked to Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed return form and directed to forward the notice if product was further distributed and advise Stryker of the beds new location. For questions regarding this recall call 269-324-6609.

Root cause

Equipment maintenance

Status

Terminated

Product code

FNL

Quantity affected

4126 units USA; 20449 inits Internationally

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.

Date initiated

2013-10-23

Date posted

2013-11-19

Date terminated

2014-05-16

Location

Portage, MI